Drugs used in the treatment of attention deficit-hyperactivity disorder (ADHD) have been associated with serious cardiovascular events and psychiatric symptoms. The Food and Drug Administration has asked the manufacturers of all ADHD drugs to create medication guides to inform consumers of those risks and of precautions they can take.

The decision was made after cases of serious cardiovascular events--stroke and heart attack in adults with certain risk factors, and sudden death in patients with underlying serious heart problems or defects--had been reported in patients taking ADHD medications at the recommended doses. The risks of both are considered to be further heightened in children with diagnosed (or undiagnosed) structural cardiovascular defects or cardiomyopathy.

In addition, there have been case reports of psychiatric events, including unwarranted suspicion, auditory hallucinations, and mania in patients with no psychiatric history. The agency's decision was also prompted by recommendations developed at the Drug Safety and Risk Management Advisory Committee meeting held in February 2006 and the Pediatric Advisory Committee meeting held in March; at the first, public testimony revealed widespread concern among parents whose children had died while taking a drug for ADHD that they had not received the full, appropriate information indicating that it could cause serious harm. The medication guides serve as an attempt to provide such information to consumers, but black box warnings will not be added to the labeling of the products at present. Committee recommendations also call for further research on the risks posed by ADHD medications.

It's imperative that a thorough health history, including cardiovascular risks and psychiatric problems, be obtained and recorded in the patient's medical record before the initiation of treatment with any ADHD drug. Nurses should assure parents that such adverse effects, while serious, appear to be rare and that the medications have been used safely in the vast majority of patients. Children treated with ADHD drugs have improved attention spans and perform better at school; their ability to interact with peers can also be improved by management of ADHD symptoms.